6-amino-4-hydroxynaphthalene-2-sulphonic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Data source

Reference

Reference Type:

other: Summary of study results

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

No guideline specified, but from available information it can be concluded that it has been conducted similar to OECD 401.

GLP compliance:

no

Remarks:

Study conducted prior to GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

6-amino-4-hydroxynaphthalene-2-sulphonic acid

EC Number:

202-000-8

EC Name:

6-amino-4-hydroxynaphthalene-2-sulphonic acid

Cas Number:

90-51-7

Molecular formula:

C10H9NO4S

IUPAC Name:

6-amino-4-hydroxynaphthalene-2-sulphonic acid

Test animals

Species:

rat

Strain:

not specified

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 14 mL/kg (5-14 ml/kg applied)

Doses:

5, 10 and 15 g/kg bw

No. of animals per sex per dose:

10 per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Based on:

test mat.

Other findings:

None of the animals died during the test or showed signs of toxicity.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Data alone cannot be used for assessment, but taking into account all pieces of information from the weight of evidence approach, it can be concluded that the GHS criteria are not met for this endpoint and hence, classification is not needed.

Conclusions:

LD50> 15 g/kg bw
Documentation is not sufficient to assess reliability of result (Klimisch 4), hence weight of evidence approach is used to fill this endpoint sufficiently.

Executive summary:

In an acute oral toxicity study (no GLP) from 1974 groups of female rats (10/dose) were given oral doses of 5, 10 and 15 g/kg bw via gavage of the test substance and were observed for 14 days. None of the animals died during the test or showed signs of toxicity. 

Oral LD50 > 15 g/kg bw